UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009301 |
|---|---|
| Receipt number | R000010916 |
| Scientific Title | Association between sleep apnea syndrome and hypertension/endocrine disorders |
| Date of disclosure of the study information | 2012/11/11 |
| Last modified on | 2012/11/09 15:57:39 |
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Basic information
Public title
Association between sleep apnea syndrome and hypertension/endocrine disorders
Acronym
SAS-HTN/Endo study
Scientific Title
Association between sleep apnea syndrome and hypertension/endocrine disorders
Scientific Title:Acronym
SAS-HTN/Endo study
Region
| Japan |
Condition
Condition
sleep apnea syndrome, hypertension, metabolic syndrome
Classification by specialty
| Medicine in general | Pneumology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the association between sleep apnea syndrome and hypertension, and to elucidate common causative endocrine factors for two diseases.
Basic objectives2
Others
Basic objectives -Others
To identify factors, especially endocrine factors, which underlie two mutually-related diseases, sleep apnea syndrome and hypertension.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure after therapy for sleep apnea syndrome (nCPAP)
Key secondary outcomes
Parameters for sleep disorders including AHI, parameters for metabolic disorders including BMI, plasma glucose, and continuous glucose monitoring, parameters for endocrine disorders including plasma/urinary aldosterone and catecholamines etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with insomnia, apnea, hypertension, or obesity-related diseases etc.
Key exclusion criteria
patients with renal dysfunction (Cr>or=3.0)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Fukunaga |
Organization
Keio university school of medicine
Division name
internal medicine (respiratory)
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio university school of medicine
Division name
internal medicine (respiratory)
Zip code
Address
TEL
03-5363-3793
Homepage URL
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We obseave parameters related sleep apnea, hypertension, and endocrine disorders in diagnosis and treatment process. We subsequently analyse them.
Management information
Registered date
| 2012 | Year | 11 | Month | 09 | Day |
Last modified on
| 2012 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010916
